Incidences, Causes, and Outcomes of Febrile Illness in Rural South and Southeast Asia

NCT04478578 | Recruiting

• 1 other identifier: BAC20001
• Study Type: observational
• Target: 100,000
• Locations: 5 countries
• Sites: 7

Brief Summary

The study will collect information to understand the causes and outcomes of febrile illness in rural areas in countries across South and Southeast Asia ( including Cambodia, Laos, Myanmar and Bangladesh). The findings will be used to identify new tests and treatments that can improve the management of febrile patients in the future. This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z

Conditions

Febrile Illness

Keywords

Febrile Illness; Incidence; Causes; Outcomes

Outcome Measures

Primary Outcomes (4)

• Local incidence of febrile illness

  The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the village level.

  From Months 0 to 24

• Overall incidence of febrile illness

  The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the regional level. These estimates will later be triangulated with and extrapolated from using health seeking behavior surveys for an estimate of the total incidence of febrile illness.

  From Months 0 to 24

• Mortality

  Case fatality rates in febrile illness

  Within approximately 1 month of first presentation to the village health worker or health facility

• Morbidity

  Duration of illness in patients presenting with a fever to the village health worker or health facility.

  Over 1 month after first presentation

Secondary Outcomes (2)

• Prevalence of pathogens in febrile patients

  Samples collected over approximately 24 months

• The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.

  Samples collected over approximately 24 months

Study Arms (1)

Patients with febrile illness

Participants from approximately 650 villages, with a target number of 100,000 episodes of febrile illness, will be enrolled into this study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an acute febrile illness of all ages presenting to village health workers (VHWs) or peripheral health facilities.

You may qualify if:

• Documented fever (≥ 37.5°C axillary), hypothermia (\< 35.5°C) and/or history of fever in the last 24 hours.
• Willingness and ability to comply with study protocol for the study duration.
• Written informed consent given to participate in the trial.

You may not qualify if:

• Currently enrolled in the study
• Accident or trauma is the cause for presentation
• Presentation ≤ 3 days after routine immunisations

Sponsors & Collaborators

• University of Oxford: lead
• Medical Action Myanmar: collaborator
• Shoklo Malaria Research Unit: collaborator
• Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit: collaborator
• Building Resources Across Communities (BRAC), Bangladesh: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Action for Health Development (AHEAD): collaborator

Study Sites (7)

Building Resources Across Communities (BRAC)

Dhaka, 1212, Bangladesh

RECRUITING

Medical Action Myanmar (MAM)

Yangon, 11201, Burma

NOT YET RECRUITING

Action for Health Development (AHEAD)

Battambang, Cambodia

RECRUITING

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)

Vientiane, Vientiane Prefecture, 01000, Laos

RECRUITING

Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Shoklo Malaria Research Unit (SMRU)

Mae Sot, Changwat Tak, 63110, Thailand

RECRUITING

Chiangrai Clinical Research Unit (CCRU)

Chiang Rai, 57000, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots (DBS)

Study Officials

• Yoel Lubell, Prof

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoel Lubell, Prof.

CONTACT

+66-857201350; yoel@tropmedres.ac

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 20, 2020
• Study Start: August 4, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of trial activities and reporting
• Access Criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Locations

TH (3); LA (1); BU (1); BA (1); CA (1)